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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ligator, hemorrhoidal
Product CodeFHN
Regulation Number 876.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
BEIJING ZKSK TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
LEO MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 318 318
2019 372 372
2020 70 70
2021 16 16
2022 60 60
2023 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 367 367
Premature Activation 146 146
Break 127 127
Positioning Failure 123 123
Detachment of Device or Device Component 44 44
Difficult to Remove 38 38
Defective Device 27 27
Use of Device Problem 21 21
Human-Device Interface Problem 16 16
Separation Failure 13 13
Mechanical Problem 12 12
Difficult or Delayed Positioning 11 11
Entrapment of Device 8 8
Failure To Adhere Or Bond 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Defective Component 7 7
Misfire 6 6
Mechanical Jam 6 6
Activation, Positioning or Separation Problem 6 6
Device Difficult to Setup or Prepare 5 5
Failure to Unfold or Unwrap 3 3
Loss of or Failure to Bond 3 3
Failure to Disconnect 3 3
Physical Resistance/Sticking 3 3
Separation Problem 3 3
Difficult or Delayed Separation 2 2
Material Deformation 2 2
Material Integrity Problem 2 2
Retraction Problem 2 2
Material Separation 2 2
Improper or Incorrect Procedure or Method 1 1
Device Reprocessing Problem 1 1
Detachment Of Device Component 1 1
Unintended System Motion 1 1
Material Twisted/Bent 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Device-Device Incompatibility 1 1
Difficult to Advance 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Component Missing 1 1
Difficult or Delayed Activation 1 1
Failure to Form Staple 1 1
Failure to Cut 1 1
Device Fell 1 1
Activation Problem 1 1
Unintended Movement 1 1
Misassembly by Users 1 1
Insufficient Information 1 1
Patient Device Interaction Problem 1 1
Material Split, Cut or Torn 1 1
Ejection Problem 1 1
Failure to Eject 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 682 682
No Clinical Signs, Symptoms or Conditions 61 61
No Known Impact Or Consequence To Patient 54 54
Hemorrhage/Bleeding 19 19
Foreign Body In Patient 15 15
No Patient Involvement 10 10
Tissue Damage 7 7
No Code Available 7 7
Blood Loss 4 4
Laceration(s) 4 4
Gastrointestinal Hemorrhage 2 2
Unspecified Tissue Injury 2 2
Melena 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Pain 1 1
Perforation 1 1
Skin Tears 1 1
Erythema 1 1
Fever 1 1

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